MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 10225

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used astotube tubing containing blood product was received for investigation.Upon visual examination of the returned component, the presence of 'pockets' of air throughout the tubing was confirmed.No leaks were identified and all connections were noted to be secured.Lot number, manufacture date and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately at the end of an erythropheresis procedure on spectra optia, the nurse noticed numerous air bubbles at multiple places in the blood warmer tubing.The nurse immediately ended the procedure to avoid the possible risk of air to the patient.Per customer, all the connections were water proof and patient showed no clinical signs and is reported in ¿fine¿ condition.Due to (b)(6) personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow--up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: per review of dlog, there were no leak alarms observed that would indicate apotential loose luer connection to the blood warmer tubing.Additionally, the procedure wascompleted successfully with no alarms, including no rlad alarms indicating air that could potentiallybe returned to the patient.Root cause: the root cause of the air bubbles noted in blood warmer tubing was due tooutgassing.No other air was noted in the set and no leaks were observed during procedure.Outgassing is a known phenomenon that occurs.During exchange procedures on spectra optia,the replacement fluids may be cold.If they are not allowed to warm to room temperature, and ifthe return blood is warmed, air bubbles may form.The reason for this "outgassing" is that gassesare more soluble in liquids at low temperatures than at higher temperatures.If at a low storagetemperature air is available to dissolve in a fluid and approaches its equilibrium solubility at thattemperature, when the fluid is warmed the air will come out of solution, because its solubility isexceeded at the higher temperature.It is typically described as chains of very small bubbles orfoam, which tend to rise toward the top of the tubing.The small bubbles may coalesce to formlarger bubbles.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8785706
• MDR Text Key: 150997153
• Report Number: 1722028-2019-00185
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 10225
• Device Lot Number: 1812103230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 08/22/2019; 09/23/2019
• Supplement Dates FDA Received: 08/30/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTOTUBE : IFT40410
• Patient Outcome(s): Other